Some different approaches have been taken in the filed of anti-snoring devices, and a number of patents disclose devices intended to be worn externally in the facial area.
U.S. Pat. No. 1,354,652, issued on Oct. 5, 1920, discloses a strip of adhesive material which can be worn over the mouth and which is intended to prevent mouth breathing and further to harmonise the facial features of a wearer, by more evenly balancing the muscles of expression. The face of the entire strip is covered with a suitable adhesive substance.
U.S. Pat. No. 4,817,636, issued on Aug. 4, 1989, discloses an anti-snoring device comprising a sheet of flexible material comprising a hypoallergenic adhesive on its back. The adhesive is further described as preferably sterile, pressure-sensitive adhesive to be applied as a film on the back face of the sheet of material. The device is designed to prevent intake of air through the mouth.
U.S. Pat. No. 5,640,974, issued on Jun. 24, 1997, and U.S. Pat. No. 5,690,121, issued on Nov. 25, 1997, disclose kits to promote effective breathing through the nasal passage. These kits are said to reduce the loudness of snoring or to eliminate snoring all together. The kits comprise a chin support member fitting underneath the user's mouth, but not covering the central portion of the mouth or even the full lips of the user.
JP 11076286, published on Mar. 23, 1999, discloses an adhesive tape for stertor prevention which comprises a net-like portion.
DE 3837277, published on May 10, 1990, discloses an anti-snoring device designed to prevent opening of the mouth during the sleep. The device comprises an adhesive tape which has an orifice, perforation or notch in a central area where it thereby can tear apart easily.
Devices covering the respiratory organs can also be found in the field of protective masks. These devices are typically provided with headbands and cover mouth and nose of a wearer. Such devices are disclosed for example in U.S. Pat. No. 5,724,964, issued on Mar. 10, 1998, and in U.S. Pat. No. 5,735,270, issued on Apr. 7, 1998. U.S. Pat. No. 4,240,420, issued on Dec. 23, 1980, and its continuation-in-part U.S. Pat. No. 4,354,489, issued on Oct. 19, 1982, disclose filter masks which comprise separate filter elements for the nose and for the mouth of a wearer.
The prior art in the general field of adhesives for attachment to the skin is particularly developed in the field of articles such as band-aids, plasters and bandages. These articles are however typically applied in an emergency situation, where for example, a cut into the skin of the wearer has occurred and absorption of the body liquids emanating from a wound is desired. In this context performance aspects of the article such as easy application and use of the product, comfortable wear as well as painless removal, and discreteness are again subordinate, to other criteria in this case such as sterility, healing support, and mechanical protection of the wound. Also such wound covering absorbent articles are mostly adhered to the skin where prior to application of the absorbent article bodily hair can be removed or where little hair grows.
In order to provide the desired level of adhesion of such bandages, the prior art typically discloses the utilisation of certain adhesives having very high cohesive strengths such as rubber based adhesives and acrylics. These adhesives are then applied as thick layers to maximise the adhesive force by which the bandage is secured to the skin of the wearer.
U.S. Pat. No. 4,699,146 discloses hydrophilic elastomeric pressure sensitive adhesives suitable for use with ostomy devices, bandages, ulcer pads, sanitary napkins, diapers, and athletic padding. The adhesive comprises at least one uradiation cross linked organic polymer and an adhesive plasticizer.
GB 2 115 431 discloses adhesives for bandages, wounds or burn dressings, EKG adhesives, sanitary napkins, diapers and ulcer pads. The adhesive comprises an irradiation cross linked organic polymer such as polyvinylpyrrolodine and an adhesive plasticizer.
However, for satisfactory use with an anti-snoring device, which may be worn each night, it is important that the adhesive has a skin compatible composition and not be harsh or aggressive towards the skin or cause skin irritation or inflammation. Also it is preferred if the adhesive is compliant with the skin of the wearer such that maximum skin surface contact between the adhesive and the skin is achieved. Moreover, it is also desirable to provide an adhesive such that the anti-snoring device can be readily removed from the wearer, without the wearer experiencing any unacceptable pain level. This is particularly important under circumstances, where the device is removed and reapplication of the device once or even a number of times is required for example to allow for better communication or intake of medicine, and to ensure the application of such devices on sensitive skin, e.g. of an elderly wearer. However, on the other hand the desired level of adhesion, albeit painless should of course also be maintained during such multiple applications of the device.
The problem of achieving the desired adhesion level is further exacerbated under wet skin conditions. In some cases, prior to the placement of the device the skin is cleaned and is usually as a result moist. The currently available adhesives, such as those containing hydrocolloid particles, however often do not immediately strongly adhere to the skin and may need to be held in place until sufficient minimum adhesion occurs. Moreover, the overall adhesive ability of such adhesives tends to be significantly reduced on wet skin surfaces per se, so that the device will typically not remain attached to the skin during wear if any pressure is exerted onto the device, for example by facial movements.
Moist and wet skin however is not just a problem which is prevalent at the device application stage as a significant amount of moisture is also generated during the use of the device from the wearer by perspiration and from moisture contained in the exhaled air. Under such circumstances currently available adhesives typically cannot absorb this moisture and again the adhesive strength is reduced to such an extent that the device will often become detached during wear. It is hence very important to provide an adhesive which provides both initial adhesion and maintenance of its adhesive strength on wet skin.
Another problem which is particularly prevalent for anti-snoring device usage is the ability of the adhesive to adhere on greasy or oily skin surfaces. The levels and types of grease and sebum naturally present on the skin vary from person to person. In addition, the wearers of such devices may want to utilise creams such as moisturising creams or other pharmaceutical creams on the area of skin typically in contact with the adhesive of the device. Thus it is also highly desirable that the adhesive exhibits an ability to adhere to greasy skin.
None of the prior art in the field of skin compatible adhesives however even recognises or addresses the problem of providing these devices with an adhesive which meets these criteria, in particular adhesives which adhere to wet skin or adhesives which adhere to oily and greasy skin and maintain their adhesiveness thereon.
For example, WO-A-97/24149 (3M) describes a lipophilic polar pressure sensitive adhesive stated to have enhanced adhesion to greasy skin, the adhesive including a hydrophilic polymer matrix, a polar organic plasticiser and at least 9 wt % of a surfactant having an HLB (hydrophile lipophile balance) value of 10 to 17. It is stated generally that the hydrophilic polymer matrix may be selected from a range of polymers including homo- and copolymers of, for example, (meth)acrylic acid and salts thereof, acrylamide, N-vinyl pyrrolidone and acrylamidopropane sulphonic acid and salts thereof. The adhesive is prepared by polymerisation in a homogeneous aqueous mixture.
The adhesive disclosed in WO-A-97/24149 is stated to have utility in biomedical electrodes, mammalian skin coverings and pharmaceutical delivery devices. However, only acrylic acid homopolymer and N-vinyl pyrrolidone homopolymer based adhesives are specifically exemplified in the working Examples. The presence of a hydrophobic monomer and/or polymer is not described.
U.S. Pat. No. 5,338,490 (Dietz et al), describes a two-phase composite pressure sensitive adhesive having discontinuous hydrophobic pressure sensitive adhesive domains within a continuous hydrophilic phase. The adhesive is stated to be ionically conductive regardless of the amount of water present, whereby the adhesive is stated to have utility in biomedical electrodes.
In view of the prior art mentioned above there still exists a need to provide an improved anti-snoring device which meets the following objectives:
The device efficiently promotes nasal breathing and thereby reduces or prevents snoring.
The device is comfortable and safe to wear.
The device is cheap to manufacture, so that it can serve as a disposable article, however, may alternatively be reusable many times.
The device allows for facial movement, namely to at least somewhat open the mouth, to speak, to cough and the like.
The device can be provided in one size to fit a large variety of consumers.
The devices can be attached to wet and/or greasy skin.
The device reliably adheres to human skin over extended periods of time.
It is another objective of the present invention to provide an adhesive, in particular of an anti-snoring device, that exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplication whilst still allowing painless removal.
It is another object of the present invention to provide an adhesive, in particular of an anti-snoring device, which upon removal from the skin of the wearer leaves no residues.
It is yet another object of the present invention to provide an adhesive, in particular of an anti-snoring device, which does not cause a cold or otherwise unacceptable temperature sensation upon application to the wearer.
An additional object of the present invention to provide an adhesive, in particular of an anti-snoring device, which provides flexibility, stretchability and contractability so that it is able to adapt to the contours of the face during all bodily movements and hence be comfortable for the wearer of the device, whilst still having sufficient adhesive capacity to ensure secure attachment during use.
It has now been surprisingly found that the above objectives can be meet by providing the anti-snoring device with the mechanical properties as defined hereinafter and comprising an adhesive as defined hereinafter.